Blood pump having a disposable blood passage cartridge with integrated pressure sensors

• US 6,887,214 B1
• Filed: 09/12/2000
• Issued: 05/03/2005
• Est. Priority Date: 09/12/2000
• Status: Expired due to Term

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: CHF Solutions, Inc.
• Inventors: Levin, Howard R., Gelfand, Mark, Bernard, Steven
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US09/660,195
• Time in Patent Office: 1,694 Days
• Field of Search: 604/5.01, 604/6.09, 604/6.11, 604 65- 67, 210/90, 210/94, 210/409, 210/461, 210/418, 210/428, 210/435, 210645-647, 210/252, 210258-260, 422 44- 48
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 Pressure isolators
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

An integrated disposable cartridge for dialysis or ultrafiltration treatment of blood is disclosed that includes integral miniature pressure sensors. Sensors are embedded in the tubing of the cartridge to measure pressure of blood or other fluids. Cartridge elements form a continuous smooth bore passage for blood that reduces probability of clotting.

Claims

1. A disposable cartridge for mounting an extracorporeal blood passage on a pump device comprising:

a. a first cartridge housing supporting said blood passage, wherein said first cartridge housing is configured to seat in a first recess of the pump device, wherein said blood passage has a blood inlet connectable to a vascular system of a patient and a blood outlet connectable to the vascular system such that blood flows through the blood passage;

b. a blood pump coupling loop of the blood passage attached to the first cartridge housing and extending outwardly from said housing, wherein a blood pump of the device engages the pump coupling loop when said first cartridge housing is seated on the blood pump device;

c. a second cartridge housing supporting said blood passage and a filtrate passage, wherein said second cartridge housing is distinct and separate from said first cartridge housing, wherein said second cartridge housing is configured to seat in a second recess of the blood pump device, and

d. a filtrate pump coupling loop of the filtrate passage extending outwardly from said second cartridge housing, wherein a filtrate pump of the device engages the filtrate pump coupling loop when said cartridge housing is seat on the pump device, wherein through said filtrate passage flows filtrate withdraw from blood in the blood passage.

2. A cartridge as in claim 1 wherein said blood passage connects said first cartridge housing to said second cartridge housing.

3. A cartridge as in claim 1 wherein an electronic pressure sensor is fixed to the first cartridge housing and is arranged to sense a pressure of the blood flow through the blood passage, wherein said sensor outputs an electrical signal indicative of the blood flow pressure to the device.

4. A cartridge as in claim 3 where a second pressure sensor is to fixed to the second cartridge housing and said second pressure sensor is arranged to sense a pressure of filtrate flow through the filtrate passage, wherein said sensor outputs an electrical signal indicative of the filtrate flow pressure to the device.

5. A cartridge as in claim 4 where the second pressure sensor is embedded in the filter and is in fluid contact with the filtered fluid.

6. A cartridge as in claim 4 further comprising a third pressure sensor arranged to sense a blood pressure in return blood passage included with the disposable cartridge.

7. A cartridge as in claim 3, where the pressure sensor and the pump coupling loop of the blood passage are rigidly fixed to an underside of the first cartridge housing and the first cartridge housing detachably attaches to the pump device adjacent to a raceway of the blood pump and said raceway receives the loop.

8. A cartridge as in claim 7 where the blood passage is formed of transparent material so that the blood flow is visible.

9. A cartridge as in claim 7 wherein the cartridge is discarded after treatment of the patient and after being released from the pump device.

10. A cartridge in claim 3 where the pressure sensor is in fluid contact with the blood.

11. A cartridge as claim 3 wherein the pressure sensor is sealed in a pressure sensor housing formed of a biocompatible and flexible material, and the sensor housing includes an integral and flexible membrane in contact with the blood and electronic sensors.

12. A cartridge as in claim 3 wherein the pressure sensor includes a pressure responsive diaphragm exposed to the blood flow and a mechanical-to-electric transducer coupled to the diaphragm and having an electrical signal output indicative of the pressure of the blood.

13. A cartridge as in claim 12 wherein the mechanical-to-electric transducer includes a strain gain bridge or capacitive element to convert displacement of the diaphragm to said electrical signal.

14. A cartridge as in claim 3 further comprising electrical signal connectors extending from the pressure sensor on the cartridge to a detachable electrical coupling on the blood pump device.

15. A cartridge as in claim 1 wherein the filtrate passage extending from the second cartridge housing discharges filtrate fluid to a filtrate collection container.

16. A cartridge as in claim 1 further comprising a pressure sensor housing affixed to the first cartridge housing for the pressure sensor, where the pressure sensor housing includes a smooth tubular channel contiguous with the blood passage fixed to the first cartridge housing and the pressure sensor is mounted flush with a wall of the first cartridge housing.

17. A cartridge as in claim 1 wherein blood pump coupling loop of said first cartridge housing extends substantially vertical when attached to the pump device and the filtrate pump coupling loop of the second cartridge housing extends substantially vertical when attached to the filtrate pump.

18. A cartridge as in claim 1 wherein said first cartridge housing has an inside side surface facing the device when the first cartridge housing is seated on the device, and wherein said blood passage is attached to the inside surface of the first cartridge housing.

19. A cartridge as in claim 1 wherein said second cartridge housing has an inside side surface facing the device when the second cartridge housing is seated on the device, and wherein said filtrate passage and a filter are attached to the inside surface of the second cartridge housing.

20. A blood circuit as in claim 1 wherein said first cartridge housing is seated on a front of the device and the second cartridge housing is seated on a side of the device.

21. A blood circuit as in claim 1 further comprising a blood filter having an input and a blood output coupled to the blood passage and a filtrate outlet coupled to the filtrate line, wherein said filter is fixed to the second cartridge housing.

22. A cartridge as in claim 21 wherein the filter is of a group consisting of a hemodialyzer, hemofilter or hemoconcentrator, and the filter includes an integral pressure sensor embedded in a blood passage wall of the filter.

23. A cartridge as in claim 21 wherein the blood filter in the second cartridge housing is substantially vertical when said second cartridge housing is mounted in the device, and wherein said filter has a bottom filtered blood outlet to the blood passage.

24. A blood circuit as in claim 21 wherein said filter is oriented vertically on the second cartridge housing when said housing is mounted on the device, and said filter inlet is at a top of the filter.

25. A disposable extracorporeal blood circuit for processing blood from a mammal and attachable to a blood treatment device having a blood pump and a filtrate pump, said blood circuit comprising:

a blood passage having a blood withdrawal port connectable to a vascular system of the mammal, a blood return port connectable to the vascular system, and a blood passage between the withdrawal port and the return port through which blood flows wherein the blood passage has a smooth and continuous wall throughout the passage;

a blood filter having a blood inlet and a blood outlet coupled to said blood passage such that the blood flows through said filter, and said filter further comprising a filtrate output coupled to a filtrate line,

a first cartridge housing to which is attached a blood loop of the blood passage and the pressure sensor, wherein the blood passage is mounted to an inside surface of the first cartridge housing such that the blood loop extends outwardly of the cartridge housing, and said first cartridge housing is detachably mountable to the blood treatment device to engage the blood loop to the blood pump when the first cartridge housing is mounted on the device, and

a second cartridge housing to which is attached a filtrate loop of the filtrate line, wherein the filtrate line is mounted to an inside surface of the second cartridge housing such that said filtrate loop extends outwardly of the second cartridge housing, said second cartridge housing is distinct and separate from the first cartridge housing, and said second cartridge housing is detachably mountable to the device to engage the filtrate loop to the filtrate pump of the blood treatment device.

26. A disposable extracorporeal blood circuit as in claim 25 further comprising a pressure sensor fixed to the inside surface of the first cartridge housing and connected to the blood passage, wherein said pressure sensor outputs a signal indicative of a blood pressure in the blood passage.

27. A disposable extracorporeal blood circuit as in claim 25 wherein the tubular blood circuit line is connectable to a roller blood pump of the blood pump.

28. A disposable extracorporeal blood circuit as in claim 25 wherein the withdrawal and return blood vessels are the same blood vessel.

29. A disposable extracorporeal blood circuit as in claim 25 wherein the blood filter in the second cartridge housing is substantially vertical when said second cartridge housing is mounted in the device, and wherein said filter has a bottom filtered blood outlet to the blood passage.

30. A disposable extracorporeal blood circuit as in claim 25 wherein blood pump coupling loop of said first cartridge housing extends substantially vertical when attached to the pump device and the filtrate pump coupling loop of the second cartridge housing extends substantially vertical when attached to the filtrate pump.

31. A blood circuit as in claim 25 wherein said first cartridge housing is seated on a front of the device and the second cartridge housing is seated on a side of the device.